Strategic Clinical Innovation Organization
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Strategic Clinical Innovation Organization (SCIO) is an early development procedure that overcomes silos and eliminates the "one at a time" method.[1][2][3] It uses computational methods to investigate epigenetics, genetics, and bioinformatics.[4] It was developed by Boston Biotech Clinical Research (BBCR).[3][5]
History[edit]
Boston Biotech Clinical Research was founded by Candida Fratazzi.[6][7] To reduce costs and speed up development, the company works with biotech, pharmaceutical, and medical device companies to create clinical protocols, programs, and efficient trials.[4]
Concept[edit]
The SCIO concept is predicated on three pillars: clinical investigation, trial design and analysis of data gathered during phases I and II, and compliance with regulatory mandates and the use of surrogate biomarkers. The aim of the SCIO method is to stratify the patient population in order to increase the proportion of patients who respond favorably to a given medication, raising it from about 20 percent to 80 percent.[4]
Using the SCIO method, non-clinical molecular proteomics can be integrated into clinical research. This improves the regulatory strategy of accumulating efficacy and safety evidence from the first human trials onwards, which in turn reduces the risk of late-stage clinical trials and better positions the product for the market.[4]
References[edit]
- ↑ https://zealjournals.com/wjapmr/sites/default/files/WJAPMR-2022-0021.pdf
- ↑ Candida Fratazzi; Jixiao Niu (January 21, 2022). "Accelerated orphan drug approval: surrogate endpoints". World Journal of Advanced Pharmaceutical and Medical Research. 2: 001–007. doi:10.53346/wjapmr.2022.2.1.0021. Unknown parameter
|s2cid=ignored (help) - ↑ 3.0 3.1 Bs, Wade Fox (September 26, 2023). "Precision medicine for all common diseases with the SCIOSM method". GSC Biological and Pharmaceutical Sciences. 24 (3): 149–153. doi:10.30574/gscbps.2023.24.3.0255 – via gsconlinepress.com. Unknown parameter
|s2cid=ignored (help) - ↑ 4.0 4.1 4.2 4.3 "BBCR". Life Sciences Review. Retrieved 2024-02-01.
- ↑ Fratazzi, Candida (2015-10-26). "Cost-effective clinical trial design to detect immunogenicity and efficacy differences between biosimilar and innovator product". Journal of Bioanalysis & Biomedicine. ISSN 1948-593X.
- ↑ https://www.hilarispublisher.com/conference-abstracts-files/1948-593X-C3-043-004.pdf
- ↑ "Challenges Exist in Implementing Biosimilars for Rheumatoid Conditions". Pharmacy Times. November 28, 2016.
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